Veterinary

APIs for animal compounding.

Carprofen, pimobendan, maropitant, trilostane, ponazuril and more, with use restrictions marked on each line.

Sealed white drums and cartons on stainless steel racking in a clean GMP storage room

How animal compounding is governed

Animal compounding from bulk is governed by FDA's animal-drug compounding guidance, not by section 503B. GFI #256 covers veterinarians and state-licensed pharmacies; draft GFI #256B (Aug 2026) covers outsourcing and other FDA-registered facilities. Items marked "Not for food-producing animals" are prohibited for extralabel use in food animals (21 CFR 530.41).

What we list (32)

503B Category 1 FDA interim policy, conditions applyCategory 2 FDA safety risk, outside the interim policyBiologic not eligible for 503A/503B compoundingWithdrawn list not for human compoundingNo 503B pathway not on the bulks list, the shortage list or in Category 1503A HHS draft policy formVeterinary animal compounding

Status as of Nov 14, 2026. Sources: FDA 503B categories list (updated Mar 21, 2025), FDA Category 2 page (current Apr 22, 2026), 21 CFR 216.24, 21 CFR 530.41, 21 CFR 600.3(h)(6), HHS FR 2026-22192. No item we list is on the 503B bulks list today. Shortage status is checked when we price your request. Labels are a starting point, not a determination for your facility.

Questions

Do the 503B labels apply to animal drugs?

No. Section 503B is a human-drug section. Lines on this page are labeled Veterinary, with any food-animal restriction noted.

Which items are restricted in food animals?

Items marked "Not for food-producing animals," including chloramphenicol, clenbuterol, ronidazole and metronidazole.

Can I start with one item?

Yes. Use the price-check form.

Every quote includes

A written price and pack size per item, the lot COA, and each item's FDA status as of the date we price it. Nothing ships until you approve the price sheet.

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